Approval Process
Lithuania is the largest of the three Baltic countries, having a population of 3.2 million. After joining the European Union in 2004, Lithuania harmonized the legislation on clinical trials with the EU, implemented Directives into the local regulations, and also started to follow the applicable EU guidelines.
- realistic start-up time: 3.5 – 4 months
Recruitment Potential
A great advantage for clinical research in Lithuania is the access to a broad group of patients who have not yet been treated with modern farmaceuticals, mainly due to economical constraints. Therefore, large groups of treatment-naïve subjects are available for all major therapeutic areas.
Estimated deaths per 100,000 population by cause (higher than world/European average):
| Diseases | Lithuania | World Average | Europe Average |
|---|---|---|---|
| Cardiovascular diseases | 781.3 | 240.9 | 465.2 |
| Neoplasms | 272.2 | 222.1 | 236.2 |
| Digestive diseases | 70.5 | 32.0 | 30.9 |
| Unintentional injuries | 67.2 | 48.0 | 40.4 |
| Mental and substance use disorders | 19.2 | 4.3 | 11.1 |
| Musculoskeletal diseases | 3.2 | 2.1 | 2.8 |
Data from World Health Organization
Lithuania has the highest ovarian cancer incidence in the world and is ranked among top 3 EU countries with regards to: leukemia, cervical, uterine, kidney, stomach and pancreatic cancer incidence.
Lithuania is a small country and usually it cannot deliver huge numbers of patients to the study (especially Phase III), on its own. But it is an excellent place to have your “first patient in” due to relatively short start-up period.
Investigators and Sites
There are approximately 145 sites in Lithuania, mainly public hospitals (including medical university hospitals) and outpatient clinics. Usually, sites are properly equipped, conducting therapeutic and diagnostic procedures according to the European standard of care.
Investigators are ICH GCP experienced, well educated, motivated and deliver high quality data.